ObesityNCT01220089
Adaptation of the Diabetes Prevention Program for Primary Care
A study testing Standard maintenance and Intensified maintenance in people with Obesity, run by Kaiser Permanente at 1 site in United States.
Trial summary
The study has two primary aims. The first aim is to assess the efficacy of adding in-person visits to the use of portion-controlled foods for long-term weight loss. The second aim is to assess the use of trained lay counselors for the maintenance of weight loss. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Standard maintenance and Intensified maintenance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 79
- Able to give informed consent
- Able to keep a food record for 7 days prior to study entry and to complete 2 screening visits and a blood draw prior to enrollment
- Willing to attend all counseling sessions, to complete study-related assessments, and to be randomized to a treatment condition after 6 months of treatment
- Has a regular primary care physician (if referred from outside the University of Colorado system)
- Body mass index (BMI) ≥ 30 kg/m2 and < 50 kg/m2
Show all 11Show fewer
- Elevated waist circumference (≥ 88 cm for women, ≥ 102 cm for men) + any one of the following:
- Glucose intolerance (fasting glucose ≥ 100 or non-fasting glucose ≥ 140, including type 2 diabetes); individuals taking medications for diabetes qualify automatically
- Elevated blood pressure (≥ 130/85), including hypertension (≥ 140/90); individuals taking anti-hypertensive medication qualify automatically
- Hyperlipidemia/dyslipidemia, including any of the following: hypertriglyceridemia (TG ≥ 150); low HDL cholesterol (< 40 for men, < 50 for women); or taking lipid-lowering medications
- Obstructive sleep apnea -
Who cannot join
- Medical conditions in which significant weight loss is normally contraindicated (e.g. pregnancy, congestive heart failure requiring diuretics, poorly controlled diabetes, Stage 4 or 5 chronic kidney disease, clinically evident cirrhosis, other severe internal organ disease); exceptions may be made if a referring physician documents that it is safe and appropriate for the individual to lose weight
- Treated for cancer within the past 5 years, except for basal cell or squamous cell skin cancer; exceptions may be made with written permission from a physician
- Myocardial infarction or stroke within the past 6 months
- Poorly controlled hypertension (≥ 160/100); may be re-screened when controlled
- Poorly controlled diabetes (hemoglobin A1c ≥ 10.0); may be re-screened when controlled
- Weight gain or loss of ≥ 5% of weight in the past 6 months; patients who have not been weight stable may be re-screened
Show all 13Show fewer
- Chronic use of corticosteroids or second-generation antipsychotic medications (exceptions may be made for individuals using these medications who have been weight stable for 6 months)
- Psychiatric diagnoses likely to affect adherence to a research study protocol (e.g., poorly controlled schizophrenia, active substance abuse)
- Untreated major depression (PHQ-9 score ≥ 20)
- Pregnant or trying to become pregnant
- Social situation precluding participation in a research study (e.g., need to care for a small child or an elderly parent)
- Prior or planned bariatric surgery
- Participation in an organized weight loss program (e.g., Weight Watchers) at the time of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
The study has two primary aims. The first aim is to assess the efficacy of adding in-person visits to the use of portion-controlled foods for long-term weight loss. The second aim is to assess the use of trained lay counselors for the maintenance of weight loss. The primary endpoint of the study will be changes in weight. Secondary endpoints will include changes in body mass index (BMI), cardiovascular risk factors, health-related quality of life, and cost-effectiveness. The addition of in-person visits with the weight loss counselor is predicted to lead to greater long-term weight loss than the use of portion-controlled foods alone.
Read the detailed description
This study will be a randomized trial of a weight control intervention, with participants recruited primarily from primary care practices at the University of Colorado. Study treatment will be delivered at the Center for Human Nutrition, an inter-disciplinary research clinic which is part of the University of Colorado School of Medicine. If needed, administrative study visits, such as for informed consent and for completion of questionnaires, may take place at offices in the Division of General Internal Medicine. Up to 200 patients will be enrolled, of which up to 125 will be provided with 6 months of high-intensity weight loss counseling. During the first 6 months, each participant will be seen for 12 counseling visits. These visits will take place at weeks 1, 2, 3, 4, 6, 8, 10, 12, 15, 18, 21, and 24. We estimate that between 10% and 20% of these patients will drop out prior to 6 months. After the first 6 months, the remaining participants will be randomly assigned to a treatment condition: Standard Maintenance or Intensified Maintenance. During months 7 to 18, individuals in the Standard Maintenance condition will receive informational handouts by mail (or e-mail) regarding weight maintenance, while those in the Intensified Maintenance condition will continue to have monthly in-person visits with the weight loss counselor ("Weight Coach").
All participants will use portion-controlled foods to replace 2 meals per day during the first 6 months of treatment and to replace 1 meal per day during months 7 to 18. Participants will purchase their own portion-controlled foods, although in-kind contributions from private industry will be sought to offset participants' food costs. The study consent form will explicitly describe estimated food costs for study participants. The cost of the meal plan, a "partial meal replacement" diet (replacement of 2 out of 3 meals per day) is not expected to increase food costs. Many participants should observe a decrease in food costs while following the meal plan.
- Conditions
- Obesity
- Being tested
- Standard maintenance, Intensified maintenance
- Keywords
- obesity, weight loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard maintenanceBehavioural
Participants will receive written materials in months 7-18
Intensified maintenanceBehavioural
Participants will continue with in-person counseling visits in months 7-18
| Study group | Role | What they receive |
|---|---|---|
| Standard maintenance | Active comparator | During months 7 to 18, individuals in the Standard Maintenance condition will receive informational handouts by mail (or e-mail) regarding weight maintenance. Receives: Behavioral: Standard maintenance |
| Intensified Maintenance | Active comparator | During months 7 to 18, individuals in the Intensified Maintenance condition will continue to have monthly in-person visits with the weight loss counselor ("Weight Coach"). Receives: Behavioral: Intensified maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight change
Measured: Weeks 1-4, 6, 8, 10, 12, 15, 18, 21, 24 & 72
Secondary outcomes (6)
change in glucose
Measured: baseline, 6 months & 18 months
change in blood pressure
Measured: baseline, 6 months & 18 months
change in waist circumference
Measured: baseline, 6 months & 18 months
change in lipids
Measured: baseline, 6 months & 18 months
change in health-related quality of life
Measured: baseline & 18 months
cost effectiveness
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2013
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American Heart Association
- Responsible party
- Sponsor
- Investigators
- Adam G Tsai, MD, MSCE, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220089
- Sponsor's protocol ID
- 10-0719
- Other IDs
- K24DK065018, 10SDG210292
- Status last verified
- Jan 2020
- First submitted
- 23 Sep 2010
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tsai AG, Juarez-Colunga E, Felton S, Speer RB, Bessesen DH, Atherly AJ. Medication costs during an 18 month clinical trial of obesity treatment among patients encountered in primary care. BMC Obes. 2015 May 29;2:24. doi: 10.1186/s40608-015-0054-4. eCollection 2015.
PubMed 26217539
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of the Diabetes Prevention Program for Primary Care
- ClinicalTrials.gov ID
- NCT01220089
- Acronym / sponsor ID
- 10-0719
- Conditions
- Obesity
- Keywords
- obesity, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American Heart Association
- Study start
- Oct 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study has two primary aims. The first aim is to assess the efficacy of adding in-person visits to the use of portion-controlled foods for long-term weight loss. The second aim is to assess the use of trained lay counselors for the maintenance of weight loss. The primary endpoint of the study will be changes in weight. Secondary endpoints will include changes in body mass index (BMI), cardiovascular risk factors, health-related quality of life, and cost-effectiveness. The addition of in-person visits with the weight loss counselor is predicted to lead to greater long-term weight loss than the use of portion-controlled foods alone.
Detailed description
This study will be a randomized trial of a weight control intervention, with participants recruited primarily from primary care practices at the University of Colorado. Study treatment will be delivered at the Center for Human Nutrition, an inter-disciplinary research clinic which is part of the University of Colorado School of Medicine. If needed, administrative study visits, such as for informed consent and for completion of questionnaires, may take place at offices in the Division of General Internal Medicine. Up to 200 patients will be enrolled, of which up to 125 will be provided with 6 months of high-intensity weight loss counseling. During the first 6 months, each participant will be seen for 12 counseling visits. These visits will take place at weeks 1, 2, 3, 4, 6, 8, 10, 12, 15, 18, 21, and 24. We estimate that between 10% and 20% of these patients will drop out prior to 6 months. After the first 6 months, the remaining participants will be randomly assigned to a treatment condition: Standard Maintenance or Intensified Maintenance. During months 7 to 18, individuals in the Standard Maintenance condition will receive informational handouts by mail (or e-mail) regarding weight maintenance, while those in the Intensified Maintenance condition will continue to have monthly in-person visits with the weight loss counselor ("Weight Coach").
All participants will use portion-controlled foods to replace 2 meals per day during the first 6 months of treatment and to replace 1 meal per day during months 7 to 18. Participants will purchase their own portion-controlled foods, although in-kind contributions from private industry will be sought to offset participants' food costs. The study consent form will explicitly describe estimated food costs for study participants. The cost of the meal plan, a "partial meal replacement" diet (replacement of 2 out of 3 meals per day) is not expected to increase food costs. Many participants should observe a decrease in food costs while following the meal plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard maintenance | Active comparator | Behavioral: Standard maintenanceDuring months 7 to 18, individuals in the Standard Maintenance condition will receive informational handouts by mail (or e-mail) regarding weight maintenance. |
| Intensified Maintenance | Active comparator | Behavioral: Intensified maintenanceDuring months 7 to 18, individuals in the Intensified Maintenance condition will continue to have monthly in-person visits with the weight loss counselor ("Weight Coach"). |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 to 79
- Able to give informed consent
- Able to keep a food record for 7 days prior to study entry and to complete 2 screening visits and a blood draw prior to enrollment
- Willing to attend all counseling sessions, to complete study-related assessments, and to be randomized to a treatment condition after 6 months of treatment
- Has a regular primary care physician (if referred from outside the University of Colorado system)
Key exclusion criteria (13 listed)
- Medical conditions in which significant weight loss is normally contraindicated (e.g. pregnancy, congestive heart failure requiring diuretics, poorly controlled diabetes, Stage 4 or 5 chronic kidney disease, clinically evident cirrhosis, other severe internal organ disease); exceptions may be made if a referring physician documents that it is safe and appropriate for the individual to lose weight
- Treated for cancer within the past 5 years, except for basal cell or squamous cell skin cancer; exceptions may be made with written permission from a physician
- Myocardial infarction or stroke within the past 6 months
- Poorly controlled hypertension (≥ 160/100); may be re-screened when controlled
- Poorly controlled diabetes (hemoglobin A1c ≥ 10.0); may be re-screened when controlled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard maintenanceParticipants will receive written materials in months 7-18 | Behavioural | Standard maintenance |
| Intensified maintenanceParticipants will continue with in-person counseling visits in months 7-18 | Behavioural | Intensified Maintenance |
Primary outcome
weight change
Time frame: Weeks 1-4, 6, 8, 10, 12, 15, 18, 21, 24 & 72
6 secondary outcomes
change in glucose
Time frame: baseline, 6 months & 18 months
change in blood pressure
Time frame: baseline, 6 months & 18 months
change in waist circumference
Time frame: baseline, 6 months & 18 months
change in lipids
Time frame: baseline, 6 months & 18 months
change in health-related quality of life
Time frame: baseline & 18 months
cost effectiveness
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Derived from this study: PubMed 26217539Tsai AG, Juarez-Colunga E, Felton S, Speer RB, Bessesen DH, Atherly AJ. Medication costs during an 18 month clinical trial of obesity treatment among patients encountered in primary care. BMC Obes. 2015 May 29;2:24. doi: 10.1186/s40608-015-0054-4. eCollection 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam G Tsai, MD, MSCE principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard maintenance and Intensified maintenance in people with Obesity, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight change (time frame: Weeks 1-4, 6, 8, 10, 12, 15, 18, 21, 24 & 72). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01220089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.